Active ingredient
Omalizumab
7 finished FDA listings contain Omalizumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OMALIZUMAB
- Dosage forms
- Injection, Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- 150 mg/1.2ml · 150 mg/ml · 300 mg/2ml · 75 mg/.5ml
- Brand names in FDA listings
- Omlyclo, Xolair, Xolair Pfs
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 302379
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 103976 | GENENTECH | 2003-06-20 | 4 |
| BLA 761399 | CELLTRION INC | 2025-03-07 | 3 |
Official labeling on DailyMed
- OMLYCLO (OMALIZUMAB-IGEC) INJECTION [CELLTRION USA, INC.] · version 6 · 2026-09-02
- XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] · version 32 · 2026-08-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.